Evolving Bioethics in Clinical Research

Behaving ethically is now-a-days being considered as an easy to deal task by every researcher. Ask any researcher about ethics and the reply you will get casually is that ‘I am doing the right thing and yes I am following ethics’; whilst the things in many cases run in real different fashion. It has always been difficult to define ethics, but in lay terms we can say – its one’s innate sense of doing the right thing. While the right and wrong can be defined again by a moral code of behavior in a civil society which comes from within. The support of law or one’s belief or professional code of conduct can well establish the difference between the non mouldable facts of life i.e. Right or Wrong.

While following ethics we may not only deal with the situation of right V/s wrong but instead the problem deepens as many a times it is concerned with a case of right v/s right. In such situations we may have to choose between – large groups of interest v/s a community or may be loyalty v/s truth; also it may be between mercy v/s justice and so on…
In Pharmaceutical Industry, such situations may be dealt with the help of established regulatory guidelines. Shannman Muskopf has written: Science asks ‘Can we?’ while Law asks ‘May we?’ and Ethics asks ‘Should we?’, hence the need of industry is to raise the bar with its regulations to such a status so as to maintain the ethical scenario intact.

In human experimentation we have witnessed evolution of bioethics after the aftermaths like tuskegee study, thalidomide disaster etc. The basic question here is whether are we going to evolve our ethics only after such mishaps or we are going to move on and revise our current system to make it robust for such forthcoming’s. Utilizing the formal tool provided to us by Belmont’s Report certainly is helping us to minimize the risks towards the patients. Three basic domains of bioethics in which these are applied are:Beneficence and Non-maleficence: Are the actions toward patients benefiting them?Autonomy: Does every individual agree towards every action applied? &Social justice: Is every action compatible with the standards of the population and society?

These guidelines are well protected by pillars of bioethics i.e. informed consent and ethics committee. Whether we need a bioethicist in a study team is always questioned; however in future we may hope to resolve these questions by staying flexible.
The ‘Golden Rule’ which states ‘Do unto others as you would have others do unto you’. This is also called the Ethic of Reciprocity. It is not the same as ‘tit for tat’ or ‘an eye for an eye’ but do good to other so as to reap the benefits for yourself.